Kinectiv®
41 catalogue numbers from 00-7848-014-01, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
41catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K071856 |
| Record published | 2018-09-14 |
| Record revised | 2020-11-19 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-7848-014-01 | 12/14 Neck Taper | In distribution |
| 00-7713-016-00 | Size 16.25 | In distribution |
| 00-7848-011-01 | 12/14 Neck Taper | In distribution |
| 65-7713-009-00 | Size 9 | In distribution |
| 00-7805-012-01 | In distribution | |
| 00-7848-030-01 | 12/14 Neck Taper | In distribution |
| 00-7805-020-01 | In distribution | |
| 65-7713-016-00 | Size 16.25 | In distribution |
| 00-7848-003-00 | 12/14 Neck Taper | In distribution |
| 00-7713-010-00 | Size 10 | In distribution |
| 00-7848-033-00 | 12/14 Neck Taper | In distribution |
| 00-7848-032-01 | 12/14 Neck Taper | In distribution |
| 00-7713-005-00 | Size 5 | In distribution |
| 00-7848-013-01 | 12/14 Neck Taper | In distribution |
| 00-7848-012-01 | 12/14 Neck Taper | In distribution |
| 00-7805-003-01 | In distribution | |
| 00-7848-012-01 | 12/14 Neck Taper | In distribution |
| 00-7848-022-01 | 12/14 Neck Taper | In distribution |
| 00-7848-022-00 | 12/14 Neck Taper | In distribution |
| 00-7713-022-00 | Size 22.5 | In distribution |
| 00-7848-023-01 | 12/14 Neck Taper | In distribution |
| 00-7713-013-00 | Size 13.5 | In distribution |
| 65-7713-015-00 | Size 15 | In distribution |
| 00-7805-002-01 | In distribution | |
| 00-7848-032-01 | 12/14 Neck Taper | In distribution |
| 00-7848-021-01 | 12/14 Neck Taper | In distribution |
| 00-7805-041-01 | In distribution | |
| 00-7848-044-01 | 12/14 Neck Taper | In distribution |
| 65-7713-007-00 | Size 7.5 | In distribution |
| 00-7848-013-01 | 12/14 Neck Taper | In distribution |
| 00-7848-042-01 | 12/14 Neck Taper | In distribution |
| 00-7848-033-01 | 12/14 Neck Taper | In distribution |
| 00-7848-011-01 | 12/14 Neck Taper | In distribution |
| 00-7713-009-00 | Size 9 | In distribution |
| 00-7848-012-00 | 12/14 Neck Taper | In distribution |
| 00-7848-011-00 | 12/14 Neck Taper | In distribution |
| 00-7848-020-01 | 12/14 Neck Taper | In distribution |
| 00-7848-034-01 | 12/14 Neck Taper | In distribution |
| 00-7848-014-01 | 12/14 Neck Taper | In distribution |
| 00-7713-015-00 | Size 15 | In distribution |
| 00-7848-043-01 | 12/14 Neck Taper | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961378 | 1996-10-08 |
| K952776 | 1996-02-14 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 96 | 2020-05-28 |
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | 24 | 2020-05-28 | |
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 116 | 2020-05-28 |
| Zimmer, Inc. | 510(k) number | 2015-05-18 | Class I | Environmental control | Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biolog | 752 | 2016-08-02 |
| Zimmer, Inc. | 510(k) number | 2009-05-29 | Not classified | Packaging process control | The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility. | 147 of both products. | 2009-12-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| 2009-05-15 | Not classified | Process control | The threads on the screw are incomplete/non-functional. | 10 | 2009-11-12 |
| 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
| 2006-08-02 | Not classified | Other | Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. | 181 of all devices | 2007-05-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.